Clinical trial · Interventional
Treatment of Primary Breast Cancer Using PDT
A Phase I/IIa, Open Label, Single Site Light Dose Escalation Trial of Single Dose Verteporfin Photodynamic Therapy (PDT) in Primary Breast Cancer
NCT02872064CI-TRIAL-00032397completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase I/IIA, open label, non-randomised, single site trial in patients with primary breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Verteporfin | Drug | Verteporfin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment with PDT
- description
- A single intravenous injection of Verteporfin (0.4mg/kg) will be administered, at least 60minutes and up to 90 minutes before laser activation. A 690nm red laser light will be delivered with a diffuser laser fibre inserted through the skin into the breast tissue, with light dose escalation after every three patients. All patients will have fixed dose of the photosensitizer but variable light dose.
- interventionNames
- Drug: Verteporfin
Primary outcomes (1)
- measure
- Establish the minimum effective light dose
- timeFrame
- One month
- description
- To establish the minimum light dose, in the range 20Joules/ (cm of light diffuser length) but not exceeding 90J/cm, required to induce an area of necrosis with a diameter of at least 12mm in line perpendicular to the fibre on microscopic examination or to achieve a plateau with no increasing necrosis as the light dose increases.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients aged 30 or over 2. A uni-focal invasive ductal breast carcinoma or discrete uni-focal site which is deemed suitable for PDT within a multifocal invasive ductal carcinoma in a single breast. 3. Patients who have opted for mastectomy or wide local excision as primary treatment. 4. Capable of giving written informed consent Exclusion Criteria: 1. Patients who are not undergoing surgery as their primary treatment. 2. Patients undergoing surgery for DCIS without invasive breast cancer. 3. Patients with Lobular cancer 4. Patients with Necrotic tumours 5. Distant metastatic disease. 6. Patients will be excluded if they have porphyria or are sensitive to verteporfin (visudyne). 7. Patients who have severe cardiovascular disease. 8. Patients with severe or uncontrolled systemic disease e.g. hepatic impairment. 9. Patients with laboratory findings that make it undesirable for the patient to participate in the trial. 10. Male breast cancer patients 11. Pregnancy and lactation. 12. No patients with any psychiatric disorder making reliable informed consent impossible. 13. Patients will be excluded if taking part in any other trial of an experimental medicine 14. Patients will be excluded if taking endocrine therapy drugs that could confound the results.
References
Publications (0)
Data not yet available
No reference posted for this study.